MAUDE Adverse Event Report: HOYA CORPORATION PENTAX TOKYO OFFICE PENTAX; VIDEO GASTROSCOPE

Model Number EG34-I10

Device Problems No Display/Image (1183); Moisture Damage (1405)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: it was caused due to a fluid damage in the scope.This report is being filed as part of the pentax backlog management plan.

Event Description

During the inspection before using, the user found that the angulation of scope was tight.The scope was badly soaked.There was no image appeared when connect to the processor.Then, the user changed another scope to finish the procedure.No harm was caused to the patient and user.

• Brand Name: PENTAX
• Type of Device: VIDEO GASTROSCOPE
• Manufacturer (Section D): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• Manufacturer (Section G): HOYA CORPORATION PENTAX TOKYO OFFICE; tsutsujigaoka 1-1-110; akishima-shi, tokyo 19600 12; JA 1960012
• Manufacturer Contact: william goeller ; 3 paragon drive; montvale, NJ 07645 ; 8004315880
• MDR Report Key: 12278860
• MDR Text Key: 265178086
• Report Number: 9610877-2021-10713
• Device Sequence Number: 1
• Product Code: FDS
• UDI-Device Identifier: 04961333245888
• UDI-Public: 04961333245888
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K180292
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EG34-I10
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1